A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Time Frame

28 days after vaccination

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Details of power calculation, definition of non-inferiority margin, and other key parameters:

Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[4]

Other relevant estimation information:

No text entered.

Statistical Analysis 2 for Percentage of Seroresponders, Ages 11 to 18 Years

Groups [1]

All groups

Statistical Test Type [2]

Non-Inferiority or Equivalence

Statistical Method [3]

ANOVA

Vaccine group difference [4]

2

95% Confidence Interval

-2 to 7

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Details of power calculation, definition of non-inferiority margin, and other key parameters:

Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[4]

Other relevant estimation information:

No text entered.

Statistical Analysis 3 for Percentage of Seroresponders, Ages 11 to 18 Years

Groups [1]

All groups

Statistical Test Type [2]

Non-Inferiority or Equivalence

Statistical Method [3]

ANOVA

Vaccine group difference [4]

12

95% Confidence Interval

6 to 18

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Details of power calculation, definition of non-inferiority margin, and other key parameters:

Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[4]

Other relevant estimation information:

No text entered.

Statistical Analysis 4 for Percentage of Seroresponders, Ages 11 to 18 Years

Groups [1]

All groups

Statistical Test Type [2]

Non-Inferiority or Equivalence

Statistical Method [3]

ANOVA

Vaccine group difference [4]

27

95% Confidence Interval

20 to 33

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Details of power calculation, definition of non-inferiority margin, and other key parameters:

Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[4]

Other relevant estimation information:

No text entered.

3. Primary:

Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years [ Time Frame: 6 days after vaccination ]